<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00195278343383</udiDi>
    <basicUdiDi>8406821BUG00160H3</basicUdiDi>
    <tradeName>CARESCAPE Central Station</tradeName>
    <deviceName>CARESCAPE Central Station Software Version 3</deviceName>
    <manufacturerName>GE Medical Systems Information Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017529</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203020292</emdnCode>
    <emdnDescription>MULTI-PARAMETER MONITORS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5867474-03</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:42:16.489Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278303219</udiDi>
    <basicUdiDi>8406821BUG00156HC</basicUdiDi>
    <tradeName>SmartMAR</tradeName>
    <deviceName>SmartMAR</deviceName>
    <manufacturerName>GE Healthcare Japan Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000009291</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030692</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS (CT) - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5869274</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:42:15.699Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278303202</udiDi>
    <basicUdiDi>8406821BUG00032GR</basicUdiDi>
    <tradeName>Deep Learning Image Reconstruction</tradeName>
    <deviceName>Deep Learning Image Reconstruction</deviceName>
    <manufacturerName>GE Healthcare Japan Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000009291</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030692</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS (CT) - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5869275</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:42:14.901Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278303196</udiDi>
    <basicUdiDi>8406821BUG00155HA</basicUdiDi>
    <tradeName>ASiR-V</tradeName>
    <deviceName>ASiR-V</deviceName>
    <manufacturerName>GE Healthcare Japan Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000009291</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030692</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS (CT) - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5869273</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:42:10.090Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278300034</udiDi>
    <basicUdiDi>8406821BUG00204GW</basicUdiDi>
    <tradeName>00195278300034</tradeName>
    <deviceName>Versana Balance</deviceName>
    <manufacturerName>GE Medical Systems CO. Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001856</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040101</emdnCode>
    <emdnDescription>INTERNAL ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5868333</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:41:04.370Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278288639</udiDi>
    <basicUdiDi>8406821BUG00161H5</basicUdiDi>
    <tradeName>CARESCAPE One</tradeName>
    <deviceName>CARESCAPE One</deviceName>
    <manufacturerName>GE Medical Systems Information Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017529</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203020202</emdnCode>
    <emdnDescription>TRANSPORTABLE/PORTABLE MULTI–PARAMETER PATIENT MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2087075-300</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:41:03.571Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278229519</udiDi>
    <basicUdiDi>8406821BUG00150GY</basicUdiDi>
    <tradeName>DV GOC Upgrade Console</tradeName>
    <deviceName>DV GOC Upgrade Console</deviceName>
    <manufacturerName>GE Medical Systems LLC</manufacturerName>
    <manufacturerSrn>US-MF-000001632</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11050104</emdnCode>
    <emdnDescription>CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD LESS THAN OR EQUAL TO 2T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DV GOC Upgrade Console</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:40:58.779Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278124609</udiDi>
    <basicUdiDi>8406821BUG00101GK</basicUdiDi>
    <tradeName>SIGNA Voyager</tradeName>
    <deviceName>SIGNA Voyager</deviceName>
    <manufacturerName>GE Healthcare Tianjin Company Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000001725</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11050104</emdnCode>
    <emdnDescription>CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD LESS THAN OR EQUAL TO 2T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SIGNA Voyager</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:40:57.167Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278118356</udiDi>
    <basicUdiDi>8406821BUG00192HG</basicUdiDi>
    <tradeName>Definium Tempo</tradeName>
    <deviceName>Medical Diagnostic Radiology Device</deviceName>
    <manufacturerName>GE HUALUN MEDICAL SYSTEMS CO. Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001189</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11031101</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B2401CAB</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:40:56.361Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278117021</udiDi>
    <basicUdiDi>8406821BUG00098HP</basicUdiDi>
    <tradeName>SIGNA Artist</tradeName>
    <deviceName>SIGNA Artist</deviceName>
    <manufacturerName>GE Healthcare Tianjin Company Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000001725</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11050104</emdnCode>
    <emdnDescription>CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD LESS THAN OR EQUAL TO 2T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SIGNA Artist</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:40:52.373Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278098603</udiDi>
    <basicUdiDi>8406821BUG00159HJ</basicUdiDi>
    <tradeName>Discovery MI Gen2</tradeName>
    <deviceName>Discovery MI Gen2</deviceName>
    <manufacturerName>GE Medical Systems, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000018315</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11020301</emdnCode>
    <emdnDescription>CT/PET SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PCM-PET0009</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:40:51.560Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278070265</udiDi>
    <basicUdiDi>8406821BUG00193HJ</basicUdiDi>
    <tradeName>Definium Tempo Pro</tradeName>
    <deviceName>Medical Diagnostic Radiology Device</deviceName>
    <manufacturerName>GE HUALUN MEDICAL SYSTEMS CO. Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001189</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11031101</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B2402CAB</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:40:49.965Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278025562</udiDi>
    <basicUdiDi>8406821BUG00038H5</basicUdiDi>
    <tradeName>SOFT-CUF, RADIAL, DINACLICK, 26 - 36 CM, 80369-5, SINGLE</tradeName>
    <deviceName>Radial-Cuf Non-Invasive Blood Pressure Cuff</deviceName>
    <manufacturerName>GE Medical Systems Information Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017529</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040180</emdnCode>
    <emdnDescription>GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5855310</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:40:45.959Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278025319</udiDi>
    <basicUdiDi>8406821BUG00034GV</basicUdiDi>
    <tradeName>SOFT-CUF, SMALL ADULT, DINACLICK, 17 - 25 CM, ENG., 80369-5, SINGLE</tradeName>
    <deviceName>Soft-Cuf Non-Invasive Blood Pressure Cuff</deviceName>
    <manufacturerName>GE Medical Systems Information Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017529</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040180</emdnCode>
    <emdnDescription>GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5855267</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:40:45.162Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278025272</udiDi>
    <basicUdiDi>8406821BUG00035GX</basicUdiDi>
    <tradeName>CLASSIC-CUF ISO, INFANT, DINACLICK, 08 - 13 CM, 80369-5, SINGLE</tradeName>
    <deviceName>Classic-Cuf Non-Invasive Blood Pressure Cuff</deviceName>
    <manufacturerName>GE Medical Systems Information Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017529</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040180</emdnCode>
    <emdnDescription>GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5855221</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:40:44.354Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278023643</udiDi>
    <basicUdiDi>8406821BUG00003GJ</basicUdiDi>
    <tradeName>SIGNA Architect</tradeName>
    <deviceName>SIGNA Architect</deviceName>
    <manufacturerName>GE Medical Systems LLC</manufacturerName>
    <manufacturerSrn>US-MF-000001632</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11050105</emdnCode>
    <emdnDescription>CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD GREATER THAN 2T AND LESS THAN OR EQUAL TO 4T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SIGNA Architect</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:40:43.569Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278017949</udiDi>
    <basicUdiDi>8406821BUG00030GM</basicUdiDi>
    <tradeName>Unity Network ID</tradeName>
    <deviceName>Unity Network ID</deviceName>
    <manufacturerName>GE Medical Systems Information Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017529</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030299</emdnCode>
    <emdnDescription>VITAL SIGNS MONITORING INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5514403</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:40:38.755Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278010797</udiDi>
    <basicUdiDi>8406821BUG00092HB</basicUdiDi>
    <tradeName>SIGNA Premier</tradeName>
    <deviceName>SIGNA Premier</deviceName>
    <manufacturerName>GE Medical Systems LLC</manufacturerName>
    <manufacturerSrn>US-MF-000001632</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11050105</emdnCode>
    <emdnDescription>CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD GREATER THAN 2T AND LESS THAN OR EQUAL TO 4T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SIGNA Premier</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:40:37.955Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278005502</udiDi>
    <basicUdiDi>8406821BUG00093HD</basicUdiDi>
    <tradeName>SIGNA Pioneer</tradeName>
    <deviceName>SIGNA Pioneer</deviceName>
    <manufacturerName>GE Medical Systems LLC</manufacturerName>
    <manufacturerSrn>US-MF-000001632</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11050105</emdnCode>
    <emdnDescription>CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD GREATER THAN 2T AND LESS THAN OR EQUAL TO 4T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SIGNA Pioneer</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:40:37.176Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278002730</udiDi>
    <basicUdiDi>8406821BUG00337HJ</basicUdiDi>
    <tradeName>ML4-20VN-D</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GE Parallel Design, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009295</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110402010101</emdnCode>
    <emdnDescription>TWO–DIMENSIONAL LINEAR–ARRAY TRANSCUTANEOUS ULTRASOUND PROBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5838851</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T14:39:51.225Z</lastUpdated>
  </row>
</eudamedExport>